High Grade GliomasPhase 1GABRIELNCT07331064
Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor
A Phase 1 study testing Gallium maltolate in people with High Grade Gliomas and Atypical Teratoid Rhabdoid Tumors (ATRT), run by Sarah Rumler.
Trial summary
In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Read more about this study
- Who is it for?
- Ages 0 months to 17 years
- Conditions the study is for
- High Grade Gliomas, Atypical Teratoid Rhabdoid Tumors (ATRT), Diffuse Midline Glioma
- What is being tested?
- Gallium maltolate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2026to 15 May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients must have a prior histological diagnosis of pediatric high-grade glioma (WHO Grade 3 or 4, including DMG/DIPG) or ATRT (WHO Grade 4) or molecular features of such tumors (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
- Patients are required to have received standard treatment for their tumor type which is considered to include at least:
- pHGG (including DIPG/DMG): maximum safe resection, focal radiotherapy. i. Addition of temozolomide, bevacizumab, or lomustine are considered of standard of care but not a requirement for inclusion.
- Addition of sites of radiotherapy to include all areas of disease as needed are considered standard of care but not a requirement for inclusion.
- ATRT: maximum safe resection, radiotherapy (focal or craniospinal), and combination chemotherapy per a nationally-accepted ATRT regimen (such as DFCI-ATRT, COG ACNS0334, or MUV-ATRT).
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- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
- Cytotoxic chemotherapy (given systemically or intraventricular/intrathecal) or other anti-cancer agents known to be myelosuppressive ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
- Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count [ANC] counts): ≥7 days after the last dose of agent.
- Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤1 (for purposes of this study, bevacizumab is considered an antibody).
- Corticosteroids:
- If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid.
- If used for symptom management related to tumor edema or elevated ICP, patient should be on a stable dose of corticosteroid for ≥7 days.
- Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for short-acting growth factor.
- Autologous stem cell infusion, including boost infusion: ≥42 days g. Cellular therapy: ≥42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells) h. h. Radiation therapy (XRT)/external beam irradiation including protons: ≥14 days after local XRT; ≥30 days after whole brain or craniospinal XRT.
- Patients must have measurable disease that can be assessed for response to treatment as defined by RAPNO for high-grade gliomas (59), RAPNO for DIPG (60), or RAPNO for medulloblastoma and other leptomeningeal seeding tumors (for ATRT) (61) that incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required (i.e., positive cerebrospinal fluid cytology).
- Male or female subjects must be 0-17 years of age.
- Lanksy/Karnofsky performance status ≥50 (refer to Appendix 1). Subjects who are wheelchair-bound because of paralysis will be considered "ambulatory" when they are up in their wheelchair.
- Patients must have adequate bone marrow function as evidenced by:
- An absolute neutrophil count (ANC) of >1,000/µL (stable off any growth factor within one week of study drug administration.
- Hemoglobin >8 g/dL.
- Platelet count >100,000/µL without transfusion within one week.
- Patients must have adequate hepatic and renal function based on the following laboratory tests:
- ALT ≤ 2 x ULN
- AST ≤ 2 x ULN
- Alkaline phosphatase ≤ 2 x ULN
- Total bilirubin ≤ 2 x ULN
- Adequate kidney function (as defined by eGFR >60 mL/min/1.72m2 as calculated by the Bedside Schwartz equation)
- Patients must be able to swallow liquid (suspension) medication, or have nasogastric or gastric tube present to give medication.
- Female subjects must meet one of the following:
- Premenstrual OR
- If subject is of childbearing potential, agree to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21 days after the last dose of study agent, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable contraception methods.)
- Male subjects of child-fathering potential must agree to one of the following:
- Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR
- Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
- Patients taking oral iron supplements or iron chelators must discontinue these medications at least one week prior to starting GaM since these agents may impact on the efficacy of GaM. Drug-drug interactions between GaM and other concomitant medications have not been reported.
Who cannot join
- Presence of other active malignant disease diagnosed within 12 months.
- Not appropriately recovered from prior therapy as defined by time frames listed in the inclusion criteria (Section 4.5.2.1).
- Known hypersensitivity to or intolerance to gallium-based medications.
- Concurrent use of cytotoxic chemotherapy is not permitted.
- Unstable or severe concurrent medical conditions such as severe heart disease, renal failure, uncontrolled diabetes mellitus, or severe lung disease.
- History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.
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- Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.
- Inability to tolerate an oral medication.
- Patients who are pregnant or nursing.
- Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
MACC Fund Center Clinical Trials Office contact
About this study
Official title: A Phase 1 Clinical Trial of Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor
In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.
Read the detailed description
We hypothesize that Gallium Maltolate (GaM) can be safely administered for the treatment of pediatric patients with pHGGs and ATRTs that have relapsed following primary treatment or are refractory to primary treatment. This, in turn, will be manifested by antineoplastic activity in patients as measured by progression-free survival (PFS) and overall survival (OS).
- Conditions
- High Grade Gliomas, Atypical Teratoid Rhabdoid Tumors (ATRT), Diffuse Midline Glioma, DIPG, Diffuse Intrinsic Pontine Gliomas (DIPG)
- Being tested
- Gallium maltolate
- Keywords
- DIPG, HGG, ATRT, DMG, relapse, refractory, progressive, high grade glioma, diffuse midline glioma, diffuse intrinsic pontine glioma, atypical teratoid rhabdoid tumor, brain tumor, pediatric
- Medical subject headings
- Recurrence, Glioma, Diffuse Intrinsic Pontine Glioma, Rhabdoid Tumor, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium maltolateDrug
oral small-molecule iron mimetic
| Study group | Role | What they receive |
|---|---|---|
| Gallium Maltolate (GaM) Arm | Experimental | single-agent GaM study, single arm. Receives: Drug: Gallium maltolate |
What is being measured
The primary outcome is the main question the study is designed to answer.
GaM tolerance
Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, identify the tolerance of pediatric patients to a specific dose of oral GaM by grading and attribution to GaM of adverse events.
Measured: From start of treatment with GaM to 30 days after completion of treatment with GaM
RP2D
Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, define the MTD, recommended phase 2 dose (RP2D), safety and toxicity of oral gallium maltolate.
Measured: From start of treatment with GaM to 30 days after completion of treatment with GaM
GaM PK levels
Measure serum gallium levels at multiple timepoints to calculate pharmacokinetic parameters in pediatric patients
Measured: From start of treatment with GaM to 6 months from start of treatment with GaM (for participants who complete 6 months of treatment).
Secondary outcomes (3)
Disease response
Document radiologic stabilization, improvement, or progression in the size of recurrent or relapsed HGGs and ATRTs as assessed by consensus recommendations from the Response Assessment in Pediatric Neuro-Oncology (RAPNO) for pediatric high-grade gliomas, diffuse intrinsic pontine gliomas, and medulloblastoma and other leptomeningeal seeding tumors.
Measured: Every 8 weeks for the first 8 cycles (i.e. prior to cycles 3, 5, 7) and then every 12 weeks until completion of therapy (i.e. prior to cycles 10, 13, 16, etc) with GaM due to disease progression or removal from study.
Survival
Document survival times to determine PFS and OS.
Measured: From start of treatment with GaM to 12 months from completion of treatment with GaM.
Quality of Life Patient Reported Outcomes
Document quality of life outcomes using validated quality of life measurements for pediatric patients (PROMIS®).
Measured: From start of treatment with GaM to 12 months from completion of treatment with GaM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start15 May 2026 (estimated)
- Primary completion15 Nov 2030 (estimated)
- Study completion15 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a modified 3 + 3 design with 1 + 1 dose escalation where both escalation and de-escalation are possible.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarah Rumler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Rumler, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331064
- Sponsor's protocol ID
- IIT-Rumler-GABRIEL
- Acronym
- GABRIEL
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: measurements of lesions (as obtained from brain/spine magnetic resonance images (MRI), adverse event descriptions and grading (including any laboratory and ancillary testing required to assess safety and health of subjects, such as blood counts, chemistries, liver testing, pulmonary function testing, and electrocardiogram) as defined by CTCAE V5, quality of life questionnaire data, survival times, and PK/biomarker information In regards to PK data, the subjects will have blood samples taken at the following timepoints to measure serum gallium concentration: on day 1 of administration just prior to drug administration, 0.5, 1, 2, 4, 8, and 24 hours post study drug administration. Additional timepoints will include troughs (i.e. just prior to study drug administration for that particular day) on day 15 of cycle 1, and day 1 of each subsequent cycle.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial of Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor
- ClinicalTrials.gov ID
- NCT07331064
- Acronym / sponsor ID
- GABRIEL / IIT-Rumler-GABRIEL
- Conditions
- High Grade Gliomas, Atypical Teratoid Rhabdoid Tumors (ATRT), Diffuse Midline Glioma, DIPG, Diffuse Intrinsic Pontine Gliomas (DIPG)
- Keywords
- DIPG, HGG, ATRT, DMG, relapse, refractory, progressive, high grade glioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sarah RumlerUniversity, hospital or other
- Study start
- 15 May 2026 (estimated)
- Primary completion
- 15 Nov 2030 (estimated)
- Study completion
- 15 May 2031 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.
Detailed description
We hypothesize that Gallium Maltolate (GaM) can be safely administered for the treatment of pediatric patients with pHGGs and ATRTs that have relapsed following primary treatment or are refractory to primary treatment. This, in turn, will be manifested by antineoplastic activity in patients as measured by progression-free survival (PFS) and overall survival (OS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a modified 3 + 3 design with 1 + 1 dose escalation where both escalation and de-escalation are possible.
| Arm | Type | Receives |
|---|---|---|
| Gallium Maltolate (GaM) Arm | Experimental | Drug: Gallium maltolatesingle-agent GaM study, single arm. |
Who may qualify
- Ages
- 0 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (37 listed)
- Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients must have a prior histological diagnosis of pediatric high-grade glioma (WHO Grade 3 or 4, including DMG/DIPG) or ATRT (WHO Grade 4) or molecular features of such tumors (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).
- Patients are required to have received standard treatment for their tumor type which is considered to include at least:
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.
- Patients must have measurable disease that can be assessed for response to treatment as defined by RAPNO for high-grade gliomas (59), RAPNO for DIPG (60), or RAPNO for medulloblastoma and other leptomeningeal seeding tumors (for ATRT) (61) that incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required (i.e., positive cerebrospinal fluid cytology).
Key exclusion criteria (10 listed)
- Presence of other active malignant disease diagnosed within 12 months.
- Not appropriately recovered from prior therapy as defined by time frames listed in the inclusion criteria (Section 4.5.2.1).
- Known hypersensitivity to or intolerance to gallium-based medications.
- Concurrent use of cytotoxic chemotherapy is not permitted.
- Unstable or severe concurrent medical conditions such as severe heart disease, renal failure, uncontrolled diabetes mellitus, or severe lung disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gallium maltolateoral small-molecule iron mimetic | Drug | Gallium Maltolate (GaM) Arm |
Primary outcome
GaM tolerance
Time frame: From start of treatment with GaM to 30 days after completion of treatment with GaM
Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, identify the tolerance of pediatric patients to a specific dose of oral GaM by grading and attribution to GaM of adverse events.
RP2D
Time frame: From start of treatment with GaM to 30 days after completion of treatment with GaM
Using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 6.0, define the MTD, recommended phase 2 dose (RP2D), safety and toxicity of oral gallium maltolate.
GaM PK levels
Time frame: From start of treatment with GaM to 6 months from start of treatment with GaM (for participants who complete 6 months of treatment).
Measure serum gallium levels at multiple timepoints to calculate pharmacokinetic parameters in pediatric patients
3 secondary outcomes
Disease response
Time frame: Every 8 weeks for the first 8 cycles (i.e. prior to cycles 3, 5, 7) and then every 12 weeks until completion of therapy (i.e. prior to cycles 10, 13, 16, etc) with GaM due to disease progression or removal from study.
Survival
Time frame: From start of treatment with GaM to 12 months from completion of treatment with GaM.
Quality of Life Patient Reported Outcomes
Time frame: From start of treatment with GaM to 12 months from completion of treatment with GaM
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. measurements of lesions (as obtained from brain/spine magnetic resonance images (MRI), adverse event descriptions and grading (including any laboratory and ancillary testing required to assess safety and health of subjects, such as blood counts, chemistries, liver testing, pulmonary function testing, and electrocardiogram) as defined by CTCAE V5, quality of life questionnaire data, survival times, and PK/biomarker information In regards to PK data, the subjects will have blood samples taken at the following timepoints to measure serum gallium concentration: on day 1 of administration just prior to drug administration, 0.5, 1, 2, 4, 8, and 24 hours post study drug administration. Additional timepoints will include troughs (i.e. just prior to study drug administration for that particular day) on day 15 of cycle 1, and day 1 of each subsequent cycle.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MACC Fund Center Clinical Trials Office contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gallium maltolate in people with High Grade Gliomas and Atypical Teratoid Rhabdoid Tumors (ATRT), run by Sarah Rumler.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Rumler, DO (414-266-2000, srumler@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GaM tolerance (time frame: From start of treatment with GaM to 30 days after completion of treatment with GaM). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.